| Study Period | 2020-2032 | CAGR | 4.9% |
| Historical Period | 2020-2022 | Forecast Period | 2024-2032 |
| Base Year | 2023 | Base Year Market Size | USD 78.6 million |
| Forecast Year | 2032 | Forecast Year Market Size | USD 115.3 million |
| Largest Market | North America | Fastest Growing Market | Europe |
The global filter integrity test market size was valued at USD 78.6 million in 2023 and is projected to reach USD 115.3 million by 2032, registering a CAGR of 4.9% during the forecast period (2024-2032). The industry is experiencing significant expansion due to the increased concentration of purity and purification systems worldwide.
Filter integrity tests are conducted to verify proper installation, validate manufacturer-specified parameters, and comply with regulatory mandates established by governing bodies before and after the fabrication of filters. These tests can also be conducted on a statistical sample of the membrane and produced devices. Currently, these processes are being carried out automatically worldwide, eliminating the need for any further actions, ensuring testing is done without contamination, and aiding in maintaining records.
The expanding biopharmaceutical industry primarily drives the market expansion, as filter integrity tests are crucial in confirming the integrity and proper installation of filters utilized in diverse bio-production processes. Additionally, this can be ascribed to the progress in disposable medical equipment, the growing quantity of service providers, and the emergence of nano-biocatalysts. Moreover, market expansion is stimulated by introducing rigorous regulatory criteria for filter quality and confirming their sterility. In addition, the increasing occurrences of chronic illnesses are accelerating the need for automated filter integrity checks to avoid any delays in the production of biotherapeutic goods.
In 2023, biotechnology and pharmaceutical businesses will utilize state-of-the-art technology and substantial research and development investments to advance healthcare innovation further. According to an article published in FPHAR in August 2022, biopharmaceuticals are considered a significant advancement of the twenty-first century and have shown superiority over chemical goods in managing diseases and improving treatment results. Global Data's findings indicate that the leading biopharmaceutical businesses experienced a significant 9.6% rise in market capitalization, increasing from USD 3.67 trillion on December 31, 2023, to USD 4 trillion on March 31, 2024.
In addition, Pfizer, an American multinational pharmaceutical and biotechnology corporation, made progress in their research and development efforts for new medicines and vaccines. In 2023, the company achieved eight necessary regulatory approvals, submitted 13 regulatory applications, and started ten pivotal studies. In addition, they have effectively finalized four acquisitions—Arena Pharmaceuticals, Biohaven Pharmaceuticals, Global Blood Therapeutics, and ReViral— which has significantly enhanced their pharmaceutical portfolio.
Furthermore, the growth of biopharmaceutical capabilities is commonly regarded as a nation's top priority and a measure of scientific progress. Investments in the development of biopharmaceuticals are strongly impacted by the significant demand for their availability, which necessitates the use of aseptic conditions during manufacturing. Therefore, the need for filters in these facilities is expected to increase due to the sterile conditions necessary, thereby promoting the construction and use of multiple filters. The surge in filter demand will drive the widespread use of filter integrity testing in biopharmaceutical production firms, resulting in market expansion.
The expenses associated with performing Filter Integrity Tests (FIT) substantially impact the dynamics of the Filter Integrity Test Market. These tests are crucial for validating the dependability and efficiency of filtering systems in industries such as pharmaceuticals, biotechnology, and food and beverage. They require a significant financial investment due to the need for precision and adherence to strict standards. The cost elements mainly consist of the procurement and upkeep of specialized testing equipment, such as bubble point, diffusive flow, and water intrusion testers. These devices are complex and require frequent calibration and maintenance to maintain precise results, increasing operational costs. For example, bubble point testers, used to confirm the pore size of membrane filters, necessitate accurate pressure measurement and control systems, which can be expensive to upkeep for operational purposes.
Furthermore, the ongoing expenses are also influenced by the consumables utilized in the testing process, such as sterilized solutions and integrity test filters. To prevent any compromise in the test findings and minimize additional costs, these materials must possess a high level of quality. Furthermore, it is essential to consider the labor expenses incurred by highly trained professionals who carry out these examinations. The technicians must undergo training in the unique protocols of filter integrity testing, which requires continuous education and certification. This process involves significant costs. Therefore, the market growth is impeded by the significant operational expenses.
The market growth is predicted to be driven by increasing regulatory standards and the implementation of guidelines for integrity testing in pre/post sterilization and filtering processes, as well as quality control, quality assurance, and validation of filtration processes. The U.S. Environmental Protection Agency (EPA) mandates that filters must undergo air leakage testing before installation and periodically after that to verify their efficacy in preventing the release of dangerous compounds into the environment.
Additionally, the U.S. Food and Drug Administration (FDA) mandates the performance of filter integrity testing for filters utilized in the production and distribution of food, pharmaceuticals, and medical devices. The U.S. Department of Energy (DOE) has implemented criteria for filter performance to guarantee energy efficiency and minimize air pollution caused by HVAC systems. Filter integrity tests are necessary to confirm that these standards are achieved. The U.S. Occupational Safety and Health Administration (OSHA) mandates regular filter integrity tests to verify that workplace filters comply with safety regulations.
Furthermore, European regulatory agencies have established specific standards and requirements in Annex-1 regarding Pre-Use Post-Sterilization Integrity Testing (PUPSIT). These measures are in place to guarantee the production of sterilized medical items and ensure filtration quality. The International Organization for Standardization (ISO) has set benchmarks for filter performance derived from globally recognized best practices. Filter integrity tests are essential for confirming adherence to these criteria.
The global filter integrity test market analysis is conducted across North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.
North America is the most significant global filter integrity test market shareholder and is estimated to grow at a CAGR of 4.6% over the forecast period. The expansion of the market in North America can be primarily attributable to factors such as substantial research and development spending and the rising innovation and development of biopharmaceuticals across the region. Before batch processing, the integrity of filters is monitored through integrity testing of sterilizing filters, which prevents the use of un integral filters. Once a set of filters has undergone sterilization, its integrity can be assessed to determine if it has been affected.
Therefore, as the demand for pharmaceuticals and biopharmaceuticals continues to rise, there is also a predicted increase in research and development spending in the United States and other nations in the region. This will ultimately drive the expansion of the market being examined. Based on the National Health Expenditure Account (NHEA), healthcare expenditure in the United States will increase by 4.1 percent in 2022, reaching a total of USD 4.5 trillion, which amounts to USD 13,493 per person. Health spending constituted 17.3 percent of the nation's Gross Domestic Product.
Additionally, according to the annual survey statistics issued in July 2022 by PhRMA member businesses, their investment in research and development in 2021 reached USD 102.3 billion, marking the most significant investment ever recorded in the United States. Therefore, the projected rise in healthcare spending in the nation is expected to influence the need for biopharmaceuticals, thus enhancing efficiency in the facilities that utilize GMP filters. Therefore, North America is anticipated to dominate the market during the projected timeframe.
Europe is anticipated to exhibit a CAGR of 5.1% over the forecast period. The Europe filter integrity test market is recognized as a very profitable region. The local market expansion can be credited to a rising consciousness among European customers and manufacturers regarding the significance of upholding product purity and safety, stimulating the demand for efficient filter integrity testing methods. Moreover, the market in the area has accelerated expansion due to technical breakthroughs and cooperation between industry players and research institutions.
Asia-Pacific is expected to experience significant growth potential due to factors such as a huge target population, a competitive landscape with local competitors, and the development of healthcare. These players drive market growth by introducing new products, forming partnerships, acquiring other companies, merging with existing entities, and expanding their operations. In December 2023, Pall Corporation, a renowned company specializing in filtration, separation, and purification, partnered with Tanajib, a prominent petroleum services company in the GCC region. They jointly announced the expansion of the Pall Arabia facility, which included manufacturing filter coalescers. This expansion aims to support the oil and gas and petrochemical industries in the Kingdom of Saudi Arabia.
In addition, in July 2023, Pall Corporation, a prominent worldwide filtration, separation, and purification technology provider, will present advanced filtration and purification technologies at SEMICON West. The increasing demand for 5G, AI, and IoT devices necessitates the development of more sophisticated chips that offer enhanced performance and energy efficiency. These advancements are expected to drive market expansion during the projected timeframe.
| Report Metric | Details |
|---|---|
| Segmentations | |
|
|
|
| Company Profiles | Merck KGaA Sartorius AG Parker Hannifin Corp PALL Corporation Donaldson Company, Inc. Pentair Ltd. 3M Meissner Filtration Products, Inc. Beijing Neuronbc Laboratories Co., Ltd. Surway Filter Analytical Technologies Limited Thermo Fisher Scientific, Inc. |
| Geographies Covered | |
| North America | U.S. Canada |
| Europe | U.K. Germany France Spain Italy Russia Nordic Benelux Rest of Europe |
| APAC | China Korea Japan India Australia Singapore Taiwan South East Asia Rest of Asia-Pacific |
| Middle East and Africa | UAE Turkey Saudi Arabia South Africa Egypt Nigeria Rest of MEA |
| LATAM | Brazil Mexico Argentina Chile Colombia Rest of LATAM |
| Report Coverage | Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends |
We can customize every report - free of charge - including purchasing stand-alone sections or country-level reports
The global filter integrity test market is segmented based on mode, test type, product type, and end-user.
By mode, the market is segmented into Manual and Automated.
The automated segment dominated the market in 2023. Automated integrity test systems or machines are offered in either a standalone or networkable setup and provide dependable, consistent integrity test data, in contrast to manual filter integrity testing. Therefore, due to this benefit, the demand for automated systems is projected to rise, further driving this category's expansion.
The manual segment is anticipated to grow at a significant CAGR. The manual bubble point test confirms that filters match the standards the manufacturer sets. It is a dependable method to check the integrity of the filter, remove particles, and ensure that it is suitable for use. This test helps to improve the quality and safety of the product.
The market is segmented by test type into Diffusion Test, Bubble Point Test, Pressure Test, and Other Test Types.
The bubble point test dominated the market in 2023. The bubble point test confirms the filters' ability to endure the necessary pressure in pharmaceutical manufacture without any leakage or contamination, ensuring the product's quality and safety. This test in biopharmaceutical production guarantees that filters retain the requisite pressure levels throughout sterilization and filtration while preserving product sterility and purity.
The forward flow (diffusion) test segment is anticipated to grow significantly over the forecast period. Diffusion flow testing is used as a regular maintenance process, particularly in essential industries such as pharmaceuticals and water treatment, to check the continuous functioning of filtration systems. This proactive strategy aids in the early detection of any potential problems, hence guaranteeing the dependability and effectiveness of filtration procedures.
The market is segmented by product type into Air Filters and Liquid Filters.
The liquid filter integrity test led the market in 2023. The increasing use of liquid filter integrity testing emphasizes the need to effectively remove impurities and maintain high product quality and safety requirements, solidifying the dominance of this testing method in the market.
The air filter integrity test segment will witness a significant CAGR over the forecast period. The progress in air filtration technology and the growing focus on preserving clean and safe indoor air quality are expected to drive the expansion of the air filter integrity test segment throughout the projected timeframe.
The filter integrity test market is segmented into pharmaceutical and biopharmaceutical companies, contract manufacturing organizations, food and beverage companies, microelectronics, and others based on end-users.
The Biopharmaceutical and pharmaceutical industry segment dominated the market. The biopharmaceutical industries prioritize enhancing their manufacturing facilities in response to the emergence of new projects. This is expected to increase the utilization of filter integrity testing procedures significantly. In addition, biopharmaceutical industries have redirected their focus toward advancing biologics and biosimilars due to improvements in bioprocessing technology. The forecast year is expected to grow in the penetration of the global filter integrity testing market due to these factors.
The food and beverage industry is projected to experience substantial growth in market share throughout the forecast period, primarily driven by strict regulatory norms and laws about food safety and efficacy requirements. In addition, implementing advanced technology in the microfiltration process has enabled the aseptic manufacture and packaging of perishable food goods. Therefore, expanding infiltration is expected to stimulate market growth during the projected time.
